FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
24601–24624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 30, 2018
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
K182066 · KOB
Cook Incorporated
Gastroenterology & Urology · 90d
Cleared Oct 30, 2018
VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides,...
K182072 · CGZ
Ortho-Clinical Diagnostics, Inc.
Chemistry · 90d
Cleared Oct 30, 2018
Wilson-Cook Mini Basket
K182381 · LQR
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 60d
Cleared Oct 30, 2018
Frozen C
K182392 · GEH
B.M. Tech. Worldwide Co., Ltd.
General & Plastic Surgery · 56d
Cleared Oct 30, 2018
AOS Calcaneal Plating System
K182466 · HRS
Advanced Orthopaedic Solutions
Orthopedic · 50d
Cleared Oct 30, 2018
DiLumen Endolumenal Interventional Platform
K182540 · FDF
Lumendi, LLC
Gastroenterology & Urology · 46d
Cleared Oct 29, 2018
HemoScreen Hematology Analyzer
K180020 · GKZ
Pixcell Medical Technologies, Ltd.
Hematology · 300d
Cleared Oct 29, 2018
HSV 1 & 2 ELITe MGB Kit
K180559 · PGI
Elitechgroup
Microbiology · 242d
Cleared Oct 29, 2018
Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
K181239 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 172d
Cleared Oct 29, 2018
ClearLink Controlled Phototherapy Equipment
K182215 · FTC
Daavlin Distributing Company
General & Plastic Surgery · 75d
Cleared Oct 29, 2018
MC3 Vascular Access Kit 21030
K182914 · DRE
Mc3 Incorporated
Cardiovascular · 11d
Cleared Oct 27, 2018
ORTHROS™ Posterior Stabilization System
K180980 · NKB
Camber Spine Technologies, LLC
Orthopedic · 197d
Cleared Oct 27, 2018
Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
K181458 · NLH
Innovative Health, LLC
Cardiovascular · 145d
Cleared Oct 26, 2018
Biomate Dental Implant System
K170732 · DZE
Biomate Medical Devices Technology...
Dental · 595d
Cleared Oct 26, 2018
Implant Planning Software
K173965 · LLZ
Inteware Co., Ltd.
Radiology · 301d
Cleared Oct 26, 2018
PENTAX Medical Video Colonoscope EC34-i10T Series
K180285 · FDF
Pentax Medical of America, Inc.
Gastroenterology & Urology · 267d
Cleared Oct 26, 2018
Polyethylene Catheter
K180286 · DQO
Cook Incorporated
Cardiovascular · 267d
Cleared Oct 26, 2018
Cook Silicone Balloon HSG Catheter
K180291 · LKF
Cook Incorporated
Obstetrics & Gynecology · 267d
Cleared Oct 26, 2018
Margolin HSG Cannula, Goldstein Sonohysterography Catheter
K180300 · LKF
Cook Incorporated
Obstetrics & Gynecology · 266d
Cleared Oct 26, 2018
Peak.me
K180487 · BZH
Breathe Me, Ltd.
Anesthesiology · 245d
Cleared Oct 26, 2018
TSI Transseptal Introducer
K181031 · DYB
Pressure Products Medical Device...
Cardiovascular · 191d
Cleared Oct 26, 2018
Invisalign System with Mandibular Advancement Feature
K181739 · NXC
Align Technology, Inc.
Dental · 116d
Cleared Oct 26, 2018
Two-Step Implant System
K181898 · HWC
Trilliant Surgical
Orthopedic · 102d
Cleared Oct 26, 2018
Dexcom G6 Glucose Program Continuous Glucose Monitoring System
K182041 · QDK
Dexcom, Inc.
Chemistry · 88d